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tv   Hearing on the FD As Fiscal Year 2017 Budget  CSPAN  March 3, 2016 1:37am-2:26am EST

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nothing new. what's happening is that the romanian population has grown up and become far more sophisticated and is demanding clean government. it is its number one demand. >> sunday night at 8:00 eastern on q and a. next, food and drug administration commissioner dr. robert califf testifies at a senate hearing about president obama's 2017 budget request for his agency. he also took questions on the fda's efforts to help combat opioid addiction. senator jerry moran choirs t ch hearing.
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>> good afternoon, everyone. we are having an abbreviated hearing today as a result of four votes being announced at 2:30. dr. califf, congratulations on your confirmation. welcome to the food and drug administration. senator merkley and i have agreed to withhold opening statements which should be to the benefit of all in the audience. we will submit those for the record. we will start with your testimony. then we will have a round of questions for as long as we're able until the votes are called. we will go a little into that time. so dr. califf, we welcome your testimony as we begin the appropriations process for this year.
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>> thank you, chairman moran and ranking member merkley. i wasse ed advised my testimonyd be sidelined. >> we would welcome you highlighting things you want us to know. if could you do that rather than reading your statement, that's to all of our benefit. >> great. i will try to do this in one minute instead of five. appreciate being here. want to acknowledge the doctor behind me who finished his term as acting commissioner. i think he has done a wonderful job. we owe him a debt of gratitude for stepping in with such he can anymorety and grace. you have the budget in front of you. we think it's a very responsible budget. several of the main priorities that i have in this are the work force at the fda. due to the increasing intensity of biological, agricultural, engineering advances, we need a
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top notch work force. much of our activity is devoted to that. second is shoring up the science base which includes a heavy exif a emphasis on quantitative analyti analytics. at the core of that is a quality system which you have all participated in helping us develop. we appreciate the funding. increase that we got last year. it has made a big difference. we still have work do there. at the core is a quality system build on high level analytics so we can deploy fda forces notice most efficient and effective manner. on the human drugs and devices side, we have several key priorities. including precision medicine which you are well aware of. it's an amazing time in biotechnology. also the compounding issue, which we're still working on. and antibiotic, anti microbal,
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which say huge issue we are facing and we want to tackle. at the core of it, for me is that we're in a continuing evolution of the fda as a sign-based public health organization with a very broad scope of activities. there are an amazing array of details that we can talk about. they are specified in my tomorrow and what we submitted. i look forward to taking your questions. >> thank you very much. let me first of all agree with you and express my appreciation for the relationship of the work at fda. very much a value of his service to the agency and to the american people. who in my view is safer because of his work. so thank you for that service and we look forward to it continuing. let me start with a complaint, however. one of the things that i have --
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at least in my view when i became chairman of this committee, we have worked hard at developing a relationship with fda. i appreciate that we have that. but i am concerned that the fda is often slow in communicating with us and with our staff. that many times -- in fact today was a perfect example. i would guess that many questions will be submitted to the fda in writing for the record. a timely response is not always the case. and specificity of answering those questions is often lacking. so i'm in an attempt to suit you up on your first hearing before the subcommittee, dr. califf, i would ask if you would assure me that you will do everything as the commissioner to see that our subcommittee, its members get appropriate, full, complete a timely responses to inquiries we make to the fda. >> my consideration of joining the fda in taking this job, outspokenness was one of the
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criteria that was said about me. it's the case. i do think the fda can do a better job of explaining what it's doing and of communicating. i've also had a hard lesson coming to the fda of learning about issues with regard to trade secrets. will call them social more rays about how things are allowed that you are well aware of. taking that into account, we will step up our communications. i can promise you that we will do that. i'm an old intensive care unit doctor. i carry a cell phone. i'm used to being called. if you feel communication is low, call me. i'm here. >> thank you very much. let me ask a specific question about rice and arsenic. last week during the budget meeting in house, it was noted the fda was making risk assessment for arsenic rice a priority. when do you plan to move and what exactly are you planning to
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release in that regard? >> well, as you well know, the issue here is estimating the risk associated with arsenic that's in rice. and estimating the benefits of rice, which has been a stable of the american diet. actually, my ancestors down between charleston and hilton head actually farmed rice for a living. so i have a little history here. the assessment is complicated, because the data are imperfect. it's in a multi-agency review. i think you are well aware of that. it's a very high priority for us to get this out. we know that people are waiting. i'm not able to give you the specifics of what will be in t. we are working on it very hard with other federal agencies. >> this decision has significant consequence to a lot of people from producers to consumers. and i would ask that you initiate a broad discussion among those affected by this
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decision before your decision is -- a conclusion is reached. that's something you intend to do? >> yes. i would say already been a good bit of discussion. but there will be a lot of discussion about it. >> are there other foods that are involved in this topic besides rice? >> this particular discussion is a rice decision, which comes in many preparations, including infant formulas and nutritional aspects. you know, it is an important decision. we're well aware of that. will affect people. we want to make sure we take that into account. >> thank you very much. let me now turn to the ranking member, senator merkley. >> thank you, mr. chairman. and congratulations, dr. califf. there's plenty of fascinating and really important issues that the fda deals with. and the one i wanted to start off with is related to the tobacco deeming regulation. that regulation has now been omb
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since october 2015. the basic rules are -- not supposed to be more than 90 days. as of today we're at 134 and counting. it has been a mystery year after year after year that this regulation haents besn't been f. while essentially we have been not acting, the addiction rate for e-cigarettes has increase d dramatically. they are targeted at kids with all kinds of flavors, double dutch chocolate. you name it, you can find it. to have a product targeted at children that's -- that effective is troublesome since it means likelihood of a likelihood of nicotine addiction with health consequences and certainly a lot of expenses for our healthcare system as well.
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what's going on? is this ever going to ing ting from omb. >> it will emerge. i'm a cardiologiscardiologist. had a busy business. i have seen people have tobacco-related issues as almost anyone on earth. so i'm strongly committed to get this out. you are also well wear of tawar complexity. we had 135,000 comments. they are many views about the detail that were aired that we have been working through. i don't think you will find anybody more committed to getting this out than i am. i have seen the consequences of tobacco-related illnesses. we need to take care of this. >> i do appreciate that your
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personal background gives you that direct insight. because some type of special change is needed here. because for 2011, 2012, 2013, 2014, 2015, now we're in 2016, very responsible individuals who said they care a lot about this issue, that they care a lot about kids, they care about -- they say we're doing everything we can, we will have it in a short period of time, and it just never happens. i'm hoping the new energy you bring can get this done. let me just note that between 2013 and 2014, e-cigarette use tripled among middle and high school students in one year. obviously, the targeting of children is very effective. it hurt a lot of people. this is something where we can make a difference for the good. i do hope you take your personal
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experiences into -- to pry this out into the public space and hopefully it will include a ban on all of these kid targeting flavors and hopefully it will include caps that are different for children to take off so we don't have as many poison cases as we have had with children. that's my hope. >> as you know, we are instructed by law to take care of the children with the tobacco act. we plan to do it. chairman upton at a meeting i was with him, pointed out that we can all understand the fda better if we think about our own family. i have a son who -- a brilliant rocket scientist son who became addicted to nicotine at age 12. this is not a matter of intelligence or will power. it's something that we need to protect children from.
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400,000 people a year are dieing from tobacco related illnesses even now. we have work do here. >> thank you, doctor. >> senator from montana. >> thank you, mr. chairman. thank you for the efficiency which you run this committee. dr. califf,confirmation. thank you for coming before the committee. the u.s. is a world leader in food production and safety. the fda maintains a role in maintaining the global leadership. in my home state of montana. agriculture is our number one industry. farmers, ranchers, play a critical role in not only feeding the ubnited states and the world. we are able to have a world class research facility at the land grant university, montana state university. in fact, i was particularly proud when i heard that msu was able to endow its first sciences
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chair who was a world leader and started earlier this year. moving forward, it's critical washington not get in the way and push policies that have the potential to hinder or even discriminate against ag research and technology that's proven to be effective, safe and proven to be row duckive. in particular, the prospects for biotechnology are bright whether it be enhancing production by increasing crop yields or helping protect the environment by requiring fewer pesticides, work reducing demand for water or lower food costs for family, i view biotech as essential to the future of food supply. there was a decision made in november of 2015 by the fda to deny a petition to require mandatory labeling of biotech in food products. do you agree with that decision?
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>> well, this is a decision that was really mandated by law in the opinion of the fda because in order to -- for the fda to mandate a label, it would be required there be a material difference. for example, as measured by a change in the nutritional composition of what you eat for a genetically engineered product. we have been unable to detect such differences, which explains our decision. >> so as a food safety agency, it sounds like would you believe -- i don't want to put words in your mouth. you believe the fda should make its decision based on sound science rather than unsubstantiated claims that might not be supported by evidence? >> we're firmly committed at the fda to base decisions and policies on the best science that we can get. >> it's good to have a doctor running it. thank you.
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i agree with you. to bring this issue home, for example, in montana, on the eastern side of our state, sugar beets are a major crop. they're an economic drive er fo our state. the source of hundreds of jobs. most are grown utilizing biotechnology. the sugar that results from the processing of a conventional sugar beet versus a biotech sugar beet is identical in both nutritional value and composition. to the point that you were describing there. if a biotech food product like sugar beets and example provided is deemed by the fda to be safe for human consumption, meet the same quality standards as a non-biotech food, and is nutritionally and essentially the same as a non-binon-biotech counterpa counterpart, should it be
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different? >> it shouldn't be labeled for that if the qualities were as you described. i want to stress something that you said. this is vitally dependent on a robust agricultural biomedical research enterprise which is not predominantly located at the fda. we have great people. it's very important to us to have first rate universities that are doing the kind of research that you describe where you are. in my previous career at duke university, we had a great biology and botany. nc state is world class in the agricultural sciences. i had a chance to do a lot of work with those folks. what we're really dependent on is a first race research enterprise that delivers the science that we immediate to make good decisions. any decision would depend on the specifics of what was measured about the plant that you are
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discussing. >> i'm out of time. i want to thank you, commissioner califf, for the thoughtful remarks. i believe it's important that the fda remains focused on its mission to help assure the u.s. is a safe food supply and abstains from marketing or labeling mandates that would have no baring on food safety. thanks very much. >> i would like to add, senator, that we did issue a guidance on voluntary liable iabeling. we have a way do that for those who think it should be labeled as such. >> thank you. >> thank you, senator. commissioner, let me turn my attention -- our attention to fisma. the topic of guidance documents. how many guidance documents is fda working on? does fda anticipate releasing -- how many do they intend to release in regard to fisma
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implementation? >> this has a fascinating issue for me. essentially, thanks to congress, we're implementing an entire new structure to prevent food-borne illness and problems rather than reacting to it. this means a system is having to be put into place. as you know, five out of the seven major rules have been issued. we have two more rules to come out shortly. then emanating from those rules will be a whole series of guidance documentdocuments. what i have come to understand about this particular area that's fascinating, empolicemen emblem emblematic is it includes the federal government. as guidance documents are put out -- i can't give you an exact number because it will depend on how things go. that's really the interpretation of the rules that would give
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people the information they need to do the implementation. since this is not the federal government saying here is exactly how you have do it, it's really a discussion occurring among multiple parties. there has to be some flexibility in here so we get it right. you might even imagine the exact way things are implemented could vary depending on the circumstances in particular regions or with particular issues. we're committed to put out the documents that are needed so this is done right. it prevents food-borne illness. >> something you just said is a reminder to me to remind you and fda, when your inspectors are reviewing practices and making a determination whether compliance is occurring, the guidance documents are just guidance. the entity being reviewed cd perform compliance in a different way than the guidance documents. that's true? >> yes.
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let me -- i'm actually excited about this topic. it may sound -- i will tell you why. a lot of my career was built on doing multi-national human clinical trials. first was so big, about 20 years ago, the fda wasn't prepared for the inspection. we ended up with meat inspectors looking at our electrocardiograms in hospitals around the world. it just wasn't ideal. before i got here, wise people figured out that our inspectors need to be aligned with the particular centers so that there's a continuity between the expertise and the center and what the inspectors are doing. when you have that expertise, it gives you the flexibility for the inspectors to look at the quality as opposed to just reading a document and saying, you have to do it this way. i'm really pleased to say, this is well under way.
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it's a kricritical part of fism. people inspecting farms and food places will have expertise in that area. they will be connected to the center so that if there are issues rather than just doing memory, they will be able to deal with it. whenever you have a complex system, it's never perfect. but people will need to let us know so we can adjust. >> you are making it the point that i want to make sure was clear, because if even though a producer or processor may not follow the guidelines, they could be in compliance. i want to make sure that your inspector would know that. >> yeah. >> it's about the result. it's not about -- fisma is designed to create safe food, nots not a regulatory checklist. i think that's what you told me you agree with. >> i agree with that. i want to pick a little finer point here. in general -- this goes -- i can speak to it from hospital quality, which has some more issues. the process typically is closely
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related to yac relate to the outcome you want. when you deefsh aviate from a sd process, you need to have a good reason for doing this. there often are good reasons. i've been on the other side of the inspection. i feel like i understand when a good reason may be in play. i wouldn't want anybody to believe we can throw process out the window. the whole reason to have fisma is so we can share knowledge and people on the farm and in the food processing places can know what the best standard for quality is. our inspectors should know that quite well, too. because if we didn't have that, we would have total chaos and no standards. we're going to be flexible. but we gotta have people understanding the process leads to the quality. does that make sense? >> it does. related topic. what's the status of the personnel necessary to find -- to pursue compliance of fisma?
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hiring mode? >> we have done a lot of hiring. we're still in hiring mode. thanks to the -- again, thanks to the funding, because it's made a huge difference. we're having to increase the work force and a realignment. remember, previously, it was geographically organized. now we're saying, you know, you have a particular job to do with a particular industry. so it's not just hiring people. it's also a tremendous amount of team building and all the things that would you do if -- >> education and train sng. >> yeah. we have states and counties involved in doing a lot of work. it's well under way. i think it's going well. we're excited about it. >> thank you, doctor. senator merkley. >> i want to turn to the current senate conversation about opioids and opioid addiction and
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all the overdoses that are occurring. the fda has come under criticism for not always using advisory panel with opioids. the fda did have an advisory panel. it recommend against approval. fda approved tchl t ed it anywa. they decided not to convene an advisory panel. what was the reason? did the fda not want to hear about the concerns from the medical professionals? why would on such an important issue with so many addiction-related issues, why would the fda have wanted to trash their advisory panel system? >> well, let me be clear. there's no interest at the fda about trashing the advisory panel system. as you know, we recently have taken a deep look at opioids.
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it is right that people are upset. i know you are dealing with it today on the senate floor. it's a national epidemic. more people dieing from overdoses than from auto accidents, which is a startling statistic. so we have got a very deep plan that was just published with everything from having advisory panels on almost everything to reframing whole issue. the question is how do you consider in a situation where maybe half of opioids that are prescribed are actually diverted to someone for whom the prescription was not written, how do you consider the societal affects in addition to the effects on the person for whom the treatment is prescribed? this is a major point of emphasis. we're changing our tactic on this. i guess the way i like to describe it is we're fighting a battle here against a very tough
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opponent. i think the fda has tried to do the best job it could. but the opponents have gotten tough quickly. we're having to change our tact. we're going do that. >> i know you weren't at the fda last year when the fda approved oxycontin for children without an advisory panel. it just kind of defies logic. so i want to ask a question again. why did the fda decide to do away with advisory panels on these dangerous drugs? >> let me address the two that you brought up specifically. hydro and peaediatric oxycontin. it will take a minute. i know we're pressed for time here. the hydro issue, it's true the panel took a vote that you have recited. but it also specified that there were criteria that might make it okay. the problem was they were concerned about the post-market system that was in place.
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i have learned there was a failing at the fda that the requirements of the advisory panel were met. it was not felt it was really disagrees with the advisory panel. it was listening to the panel and making the changes. but on that one, it's complete agreement as you are aware now based on our plan that had we to do it over again, we would have met with the advisory panel again and reviewed, had we done what you specified, so it would currently be something would you agree with. the pediatric oxycontin, this is a very important one that i think technically -- i don't think it's correct to call it an approval. oxycontin has been available for children. they there are 10,000 children a year. if you have seen a child with sickle cell disease, for example, which is one of the serious illnesses for which chronic opioids are needed for
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very severe pain or a child dieing of cancer, the drugs are being prescribed. we think for children, mostly appropriately so. pediatricians wouldn't use the drugs ad hoc. it was to make proper dosing available as opposed to using the way it was used. it was associated with a post-market commitment to make sure we're able to track what's done with oxycontin. having said that, we learned a lot by seeing what happened. i was at the fda when this happened, because i was at medical products and tobacco. i don't want to be shirking responsible here. seeing the public reaction to this, we're going to have two consecutive pediatric advisory panels to review all of our approaches to opioids in children. they are scheduled. they will be very intentative. we will certainly listen to the
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advice. finally, if i could note one other thing about this. we do have a letter that was recently in the boston globe from the american academy of pediatrics and from the chair of the standing pediatric advisory committee of the fda saying they thought our decision was a correct decision to give doctors dosing information so they would know the right doses to use when these drugs are indicated. having said that, we're going to use advisory panels for these things. >> mr. chairman, can i ask one more question here? i'm glad to hear that the commitment to advisory panels is going forward. did you require on the label warnings about the addiction properties? is that on all the opioids now? if not is that something that can be done right away? >> it is on all the opioids.
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we're going to strengthen the labels, which is part of the plan you see. one thing that happened is there were a series of things done for long-acting opioids, so-called erla extended release long acting. we're updating the information to put out sterner warnings. i think if you read what's in the label, it's pretty clear what the problems are. but we have learned it hasn't gotten through. we need to get to prescribers. the prescribing really needs to be brought under control. >> i can tell you, it doesn't get through. just recently, for example, my daughter had her wisdom teeth extracted. when she came home and she had her prescription, i said to her, you know, we have to be careful with dangers of addictions. it was one of those oh, dad moments. if the dentist talked to her about the dangers after disc, that would have carried weight.
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if the pharmacist had talked with her about the dangers of addiction. but it was crazy to her, what's this crazy idea that she's hearing from her dad? as i talked to people, very few get education from their doctors about the substantial risks involved. just think in oregon, 4 million people last year, 100 million opioid pills prescribed. 100 million. >> if i may, i feel qualified to talk about this. because up until ten months ago i was a practicing doc. started in intensive care and had an outpatient practice. recently, it wasn't so big because i had administrative responsibilities. still saw it all. the medical practice issue here is profound. i know you are all going to be dealing with it actually today. it's our stated position in the
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new england journal, there should be mandatory education. a critical thing as you talk about this, back up one second, we spent yesterday with our science board in a public meeting. one of your colleagues actually came out to the fda to give public testimony. a really critical thing is here is mandatory education. not just about opioids. the pain that people have is real. there are 10 to 12 million people with severe chronic pain. we also heard from them. the doctors need to be trained about how to deal with pain. and then thousand deal with the opioid part of pain. we have a voluntary program which is part of the commitment, the companies have to pay for it but independent providers do it. one problem with voluntary education is the people most likely to volunteer to take it are the ones that immediate it the least. we're officially in favor of mandatory education. we think it's one of the most important things that could be done.
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>> thank you. >> commissioner, i saw recently that the director of the center for vet naerinary medicine announced she was leaving. i would ask you and encourage you to consider the appointment of a veterinary practitioner to that position. have you thought about what's next in this regard? >> i have. we will do a national search. by standard, we need to have it open to all types people who might apply. he will note that i have a proclifshive towards veterinari veterinarians. we have a family wedding coming up in colorado. my future daughter-in-law, just graduated from the veterinary school. i heard a veterinarian perspective. i have a love for veterinarians because of that.
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we have to open it up to everyone. being a medical doctor and now in charge of the fda, i understand what you are sasying the concerns. it would mean someone from that backgroundhelpful and someone with experience in the field. >> thank you. let me talk a moment about biosimilars and highlight language that was included in the omnibus spending bill directing the commission to respond -- the fda to respond. what the language says is -- first of all, i preface this by saying, there's lots of folks in the industry would who like to have input, understanding analysis as the biosimilar program is developed naming labels, interest are change built and indication extrapolation and our language in the appropriation bill that you are now operating under
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directed that the committee be provided with an estimated time line by which the agency will finalize all pending drafts, draft biosimilar guidance documents and regulations. the committee expects to receive this no later than 60 days after enactment. it occurred in december. and we have not had a response to that directive. what's the status? what can we expect? >> it sounds lame to say i'm going to have to get back to you on details of the timing. but we will get back with you. i will point out, i was in charge of the clinical trial for the first buy biologic in cardiology. it ended up working a logic. i'm aware of the issues. they are complex. i think we're very close. i will give a shout out to janet
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woodcock and her team who have been working on this. they are not only regulators, they are world authorities on the chemistry and biology of buy logic drugs. weaver going to get there out as quickly as we can. we have 59 compounds in the pipeline for the biosimilar program. if we don't get this out soon, it's going to be difficult for people to navigate and know what they need to do. i hear you and we will get back to you. >> let me highlight a gao report that was released in december of 2015 on fda's information technology infrastructure. that report made a recommendation that fda define schedules and milestones for incorporating into its i.t. plan elements that align the mission and business strategy and fully impolicemen the plmreplement th. we have seen problems in federal agencies and their use of i.t.
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and i would highlight the goa report for your consideration and information and encourage the fda to take an active role if meeting recommendations of the goa report. this matters a lot to efficiency and good government. >> let me just say, it was an interesting experience from come from a major university with a lot federal funds and then to step inside of the federal system on i.t. i appreciate your concerns. what i would say is that in the past, the primary issue at the fda has been protecting all of the highly protected trade secret information that's under constant attack. that's gone well. we have done that well. but i'm pleased to say we hired a new cio just as i came on board. he is a great guy. he has experience in the federal government and the private sector. we read the goa report.
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we're complying with t. we're working closely with the goa to close the gaps. what it pointed out was there was a plan for i.t. inside the fda but not a marriage of the i.t. plan with the overall strategic plan of the organization. i can assure you on a science-based organization, if you don't have good knowledge management infrastructure and the way the fda works, it's a lot of transactions, a lot like a business. people put in applications. they have to be dealt with. if you don't have those systems working, you have a deficit that's going to hurt you. we're very focused on it. i'm confident we will comply. >> we have just a few more minutes. the vote has been called. let me ask senator merkley if he has any brief, short follow-up questions that he would like to make sure he asks. >> thank you, mr. chairman. i want to go back to the opioid situation. i mentioned the number of pills in oregon, 100 million pills
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prescribed for 4 million. it seems like there must be ways to take this on. so many people say, hey, i needed eight pills and i had 30 left over or whatever. not only are they not getting educated from their doctors about the addiction risk, they're not being told and these represent a significant problem these leftover pills. this is what i want you to do. this is how you get rid of the pills. this is how you return them to me or this is how you -- can we -- is it worth thinking about smaller number of pills being prescribed initially? by the way, i was shocked to read that the number -- the percent that virtually everyone who suffered an opioid overdose were able to go back and fulfill -- get a prescription filled again, even after their overdose. in other words, there's something -- maybe we don't have
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a tracking database. people are getting prescriptions in various places. what can we do? it's crazy, 100 million pills in oregon. >> there's no doubt about this. i should reveal that in my academic career, just before coming to fda, i was involved in a network to deal with opioid abuse, the nih funded network. we oversaw a project kaiser was doing to organize its health system to offer alternative tea team-based approaching to reduce opioid prescriptions. we had a grant together with the cms innovation center to develop electronic health record systems to identify and intervene people who are at high risk in rural southern counties in west virginia, mississippi and north carolina. so i have done a lot of work on this topic. you are fair to call it crazy. if i could take one minute -- i know you have to vote.
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ten years ago, there was a call for america's doctors to stamp out pain. it was a quality measure in hospitals. doctors were taught that had you to get the pain level down to zero. that was a goal. there obviously was an overreaction. it's extreme. it created a national epidemic. we have to reign it in. the fda has a role. our directions are clear. if you talk to doctors, none of them read medical -- read drug labels. i didn't. it's a deriverive instructions that go to the doctor and the education. we are one of multiple agencies in congress and states that need to work together. remember, the medicine is regulated mostly at the state level. we're prohibited from regulating the practice of medicine. we're going to be very outspoken about this along with you. we have to put practical things in place. one -- quick comment about arbitrary restrictions on
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numbers of days. it's complicated, because many of the people who actually do need opioids for chronic pain, we had amazing testimony by someone from walter reed yesterday who is involved with tens of thousands of veterans that have had amputations. many of them are in extended living facilities or places where they can't get back to the doctor to get their prescriptions refilled. i would urge against an arbitrary restriction. we have got to work together to convince doctors that they need to exert the utmost care with the fewest pills and the clear instruction for disposal if you done need everything in the bottle. >> dr. califf, thank you very much. thank you for your testimony today. i was impressed with your level of knowledge and expertise. i wish you well as you lead the food and drug administration. my intention is, as i indicated when we visited in my office, that i would have expected to have a conversation today about
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zika. about opioids, which senator merkley was interested in and about cancer -- the cure of cancer and the moonshot effort. i welcome those to continue. my hope is that a few months into your job, as we get through the appropriations process, that we would invite you back, you would accept and we would give not only senator merkley and i but other members a chance to have a more in-depth conversation about issues facing the fda. >> i would appreciate that. my testimony said that i didn't get to talk about, we need the enter change and guidance to get it right. we base everything we do on science and insist we get better and better at the science. but policy, obviously, involves an intersection of culture and science. you are the intersection. we look forward to working with you. >> thank you very much. mr. tyler, thank you for joining us. you have been good at handing notes to the commissioner. i would take the opportunity to formally conclude this hearing as soon as i find the magic words.
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for members of the subcommittee, any question that you would like to submit for the record, should be turned into the subcommittee staff within one week. sch wednesday, march 9th. we would appreciate if we could have responses from the fda within four weeks of that time. again, commissioner, thank you. acting commissioner, thank you very much for your leadership in the agency. we stand adjourned.
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"c-span" washington journal and coming up tomorrow morning, new york republican congressman chris gibson and minnesota democratic congressman tim walz discuss opposition to the draw down of the land forces to the lowest levels since world war ii and the chair of the election i ai sis ta assistance thomas hicks will talk. live beginning at 7:00 a.m. eastern tomorrow morning. join the discussion. some live events to tell you about. former republican presidential candidate mitt romney will weigh in on the presidential race following the super tuesday

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